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A RECOMMENDED TREATMENT OPTION
Glasdegib (DAURISMO) is a recommended treatment option in the National Comprehensive
Cancer Network Clinical Practice Guidelines in Oncology (NCCN Guidelines®) for adults
with newly diagnosed AML who are not candidates for or decline intensive induction therapy 3
IMPORTANT SAFETY INFORMATION (CONT’D)
Blood Donation: Advise patients not to donate blood or blood products while taking DAURISMO and for
at least 30 days after the last dose, because their blood or blood products might be given to a female of
reproductive potential.
QTc Interval Prolongation: Patients treated with DAURISMO can develop QTc prolongation and ventricular
arrhythmias, including ventricular fi brillation and ventricular tachycardia. Monitor electrocardiograms (ECGs)
and electrolytes. Concomitant use of DAURISMO with drugs known to prolong the QTc interval and CYP3A4
inhibitors may increase the risk of QTc interval prolongation. In patients with congenital long QT syndrome,
congestive heart failure, electrolyte abnormalities, or those who are taking medications known to prolong
the QTc interval, more frequent ECG monitoring is recommended. Interrupt DAURISMO if QTc interval is
>500 ms and discontinue permanently for patients who develop QTc interval prolongation with signs or
symptoms of life-threatening arrhythmia.
Adverse Reactions: Most common adverse reactions (incidence ≥20%) are anemia, fatigue, hemorrhage,
febrile neutropenia, musculoskeletal pain, nausea, edema, thrombocytopenia, dyspnea, decreased appetite,
dysgeusia, mucositis, constipation, and rash.
Drug Interactions: Co-administration with strong CYP3A4 inhibitors increased DAURISMO plasma
concentrations, which may increase the risk of adverse reactions including QTc interval prolongation.
Consider alternative therapies that are not strong CYP3A4 inhibitors during treatment with DAURISMO and
monitor patients for increased risk of adverse reactions including QTc interval prolongation. Strong CYP3A4
inducers should be avoided due to decreased DAURISMO plasma concentrations, which may reduce effi cacy.
Lactation: Because of the potential for serious adverse reactions from DAURISMO in a breastfed child,
advise women who are taking DAURISMO not to breastfeed or provide breast milk to infants or children
during treatment and for at least 30 days after the last dose.
INDICATION
DAURISMO is a Hedgehog pathway inhibitor indicated, in combination with low-dose cytarabine, for the
treatment of newly diagnosed acute myeloid leukemia (AML) in adult patients who are ≥75 years old or who
have comorbidities that preclude use of intensive induction chemotherapy.
Limitation of Use: DAURISMO has not been studied in patients with the comorbidities of severe renal
impairment or moderate-to-severe hepatic impairment.
Please see Brief Summary of full Prescribing Information, including BOXED WARNING, on the following page.
References: 1. DAURISMO Prescribing Information. New York, NY: Pfi zer Inc. 2. Data on fi le. Pfi zer Inc, New York, NY. 3. Referenced with
permission from the NCCN Clinical Practice Guidelines in Oncology (NCCN Guidelines®) for Acute Myeloid Leukemia V.3.2018. © National
Comprehensive Cancer Network, Inc. 2018. All rights reserved. Accessed December 4, 2018. To view the most recent and complete version
of the guideline, go online to NCCN.org. NCCN makes no warranties of any kind whatsoever regarding their content, use or application and
disclaims any responsibility for their application or use in any way.
PP-GDG-USA-0099-02
© 2019 Pfi zer Inc.
All rights reserved.
Printed in USA/January 2019